| CTRI Number |
CTRI/2022/12/048203 [Registered on: 16/12/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Tiladipanchaka Paneeya Kshar and Shvadanshtradi Kwath in the management of Ashmari w.s.r. to Urolithiasis. |
|
Scientific Title of Study
|
A clinical study of Tiladipanchaka Paneeya Kshar and Shvadanshtradi Kwath in the management of Ashmari w.s.r. to Urolithiasis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Kumar Guleria |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Shalya Tantra Madan Mohan Malviya Government
Ayurved College Ambamata Scheme Radaji Circle Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9461145323 |
| Fax |
|
| Email |
guleriaharshitaravindra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
M.D. and Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Shalya Tantra Madan Mohan Malviya Government
Ayurved College Ambamata Scheme Radaji Circle Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namo Narayan Meena |
| Designation |
M.D. and Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Shalya Tantra Madan Mohan Malviya Government
Ayurved College Ambamata Scheme Radaji Circle Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9928871125 |
| Fax |
|
| Email |
drnamorajat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College |
| Address |
Ambamata Scheme Radaji Circle Udaipur Rajasthan 313001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Kumar Guleria |
Madan Mohan Malviya Government Ayurved College |
OPD NO. 1 PG
Department of Shalya
Tantra Associated
Hospitals of Madan
Mohan Malviya
Government Ayurved
College Udaipur
Rajasthan 313001
Udaipur
RAJASTHAN |
9461145323
guleriaharshitaravindra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tiladipanchaka Paneeya Kshar, Reference: Sushruta Sutra 7/2, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tiladipanchaka Paneeya Kshar, Reference: Sushruta Sutra 7/2, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -(2) Medicine Name: Shvadanstradi Kwath, Reference: Chakradatta 34/30, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Radiological evidence of stone (up to 12 mm) in Kidney, Ureter and Urinary Bladder |
|
| ExclusionCriteria |
| Details |
1. Stone size more than 12 mm.
2. Gross Hydronephrosis.
3. Pyelonephritis.
4. Uncontrolled Diabetic Mellitus and Hypertension
5. Impaired Renal Function.
6. Poorly Functioning Kidney.
7. Patients with obstruction in urinary passage.
8. Any other complication of calculus.
9. Patients undergoing treatment for any other serious illness
10. Any malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in sign and symptoms of Ashmari wsr Urolithiasis.
2. Reduction in size and number of stone. |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in sign and symptoms of Ashmari wsr Urolithiasis.
2. Reduction in size and number of stone. |
1 Week, 2 Week, 3 Week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a Clinical study on Tiladipanchaka Paneeya-Kshar and Shvadanshtradi Kwath in the management of Ashmari w.s.r. to Urolithiasis. It is Computer generated randomised, parellel group study. In this group A (15 patients) is administered with Tiladipanchaka Paneeya-Kshar, and group B (15 patients) with both Tiladipanchaka Paneeya-Kshar and Shvadanshtradi Kwath. |